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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY UTS PRECURVED ULTRA TAPER SPHINCTEROTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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COOK ENDOSCOPY UTS PRECURVED ULTRA TAPER SPHINCTEROTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number G22430
Device Problems Material Fragmentation (1261); Material Separation (1562)
Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/02/2021
Event Type  malfunction  
Manufacturer Narrative
Pma/510(k) # k172665. The investigation is on going. A follow-up emdr will be provided with the completed investigation.
 
Event Description
During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook uts pre-curved ultra taper sphincterotome. The cutting wire completely detached inside the patients body. The wire was unable to be found. This wire was unable to be found; it is unknown if it is still in the body, or may have came out during removal of the device and lost in the procedure room. It is unknown if the detached portion of the cutting wire is still in the body. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
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Brand NameUTS PRECURVED ULTRA TAPER SPHINCTEROTOME
Type of DeviceKNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
Manufacturer (Section G)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
Manufacturer Contact
kaylin davis
4900 bethania station rd
winston-salem, NC 27105
3367440157
MDR Report Key11748257
MDR Text Key267663123
Report Number1037905-2021-00173
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 05/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/06/2022
Device Model NumberG22430
Device Catalogue NumberUTS-30M
Device Lot NumberW4223535
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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